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A Study of 15 and 20 mg of Lu AA21004 in Major Depressive Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
H. Lundbeck A/S
ClinicalTrials.gov Identifier:
NCT01323478
First received: March 24, 2011
Last updated: October 26, 2012
Last verified: October 2012
History of Changes

March 24, 2011
October 26, 2012
April 2011
September 2012   (final data collection date for primary outcome measure)
To evaluate the long-term safety and tolerability of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD who have completed the lead-in Study 13267A. [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01323478 on ClinicalTrials.gov Archive Site
  • To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by MADRS. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    MADRS: Montgomery and Åsberg Depression Rating Scale
  • To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by CGI-S. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    CGI-S: Clinical Global Impression Scale-Severity of Illness
  • To evaluate the therapeutic effect of flexible doses of Lu AA21004 (15 and 20 mg/day) over a period of 52 weeks in patients with MDD as assessed by HAM-A. [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    HAM-A: Hamilton Anxiety Rating Scale
Same as current
Not Provided
Not Provided
 
A Study of 15 and 20 mg of Lu AA21004 in Major Depressive Disorder
A Long-term, Open-label, Flexible-dose, Extension Study Evaluating the Safety and Tolerability of Lu AA21004 (15 and 20 mg/Day) in Patients With Major Depressive Disorder

To evaluate the long-term safety and tolerability of flexible doses, 15 and 20 mg/day, of Lu AA21004 over a period of 52 weeks in patients with Major Depressive Disorder (MDD)

Depression is a common mental disorder that presents with depressed mood, loss of interest or pleasure, disturbed sleep or appetite, low energy, feelings of guilt or low self-worth, and poor concentration. Depression may become chronic or recurrent and lead to substantial impairments in an individual's ability to take care of his or her everyday responsibilities. The need for the treatment of the depressive episode beyond the acute period of treatment has been well documented and the duration of treatment is usually set at about 6 months. The adverse event profile plays a large role in the choice of antidepressant therapy and safety aspects of a drug in relation to the duration of treatment have to be addressed.
Interventional
Phase 3
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Major Depressive Disorder
Drug: Lu AA21004
Flexible dose 15 - 20 mg/day
Other Name: Vortioxetine
Experimental: Lu AA21004 flexible dose 15 - 20 mg/day
Intervention: Drug: Lu AA21004
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
71
October 2012
September 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients who completed 8-week short-term treatment study (Protocol ID 13267A) for Major Depressive Episode immediately prior to enrolment in this extension study

Exclusion Criteria:

  • Any current psychiatric disorder other than MDD as defined in the DSM-IV TR
  • Female patients of childbearing potential who are not using effective contraception
  • Use of any psychoactive medication

Other protocol-defined inclusion and exclusion criteria may apply.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Estonia,   Finland,   Latvia,   Norway,   Slovakia,   Sweden
 
NCT01323478
13267B, 2010-024198-38
No
H. Lundbeck A/S
H. Lundbeck A/S
Not Provided
Study Director: Email contact via H. Lundbeck A/S LundbeckClinicalTrials@lundbeck.com
H. Lundbeck A/S
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP